MAUDE Adverse Event Report: QUEST MEDICAL, INC. RLV-2100 VACUUM RELIEF VALVE; CARDIOPULMONARY SUCTION CONTROL DEVICE

Model Number	4103202
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	10/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There are no more devices of the same lot remaining in inventory for evaluation.Quest medical, inc.Has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Quest medical, inc.Defers to the patient's physician regarding medical history.
Event or Problem Description
The distributor reported an issue one of their customers encountered during use of the cardiopulmonary suction control device.The report stated the device was part of a "sucker line", a negative pressure line used during an ecmo procedure.The report stated that the one-way valve was stuck open, and to resolve the issue a cap was placed on the negative pressure release and another valve was placed proximal to the open valve.The report stated that blood was lost that required a blood transfusion to the patient and an acute pressure drop was observed as a result of the alleged event.The report was completed and no further patient impact was reported.The device was discarded by the end-user and not returned to the distributor or manufacturer for evaluation.The device is a cardiopulmonary suction control device sold in bulk, non-sterile form to the distributor for additional processing prior to end-use.
Additional Manufacturer Narrative
The device was not returned to the manufacturer for evaluation.There were no more devices of the same lot remaining in inventory for evaluation.The device history record for the lot was reviewed and no devices were rejected and no specific manufacturing yield issues were reported similar to the reported complaint condition.

• Brand Name: RLV-2100 VACUUM RELIEF VALVE
• Common Device Name: CARDIOPULMONARY SUCTION CONTROL DEVICE
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 6100637
• Report Number: 1649914-2016-00055
• Device Sequence Number: 293791
• Product Code: DWD
• UDI-Device Identifier: 20634624413225
• UDI-Public: 20634624413225
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K864503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 4103202
• Device Lot Number: 050562
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2016
• Supplement Report FDA Received Date: 12/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention